How to set up a clinical trial

Rachel Thomas, Emma Aitken, Jean Antonelli, Lorna Marson

Research output: Contribution to journalArticlepeer-review


Clinical trials are considered the gold-standard method for the evaluation of healthcare interventions. However, randomised control trials are complex to perform and many researchers, especially those in the early stages of their career, can find it challenging to know where to start set up, contribute to, or lead a trial.
This guide provides an introduction to trials and also practical advice to help potential investigators complete their clinical trial to time and to budget by signposting the pathway through the complex regulatory landscape.

The authors draw on their own recent experiences of running clinical trials and provide tips and tricks for troubleshooting common problems encountered including trial design and documentation.

Key messages:

• A clear hypothesis and good trial design simplifies protocol writing.
• Involve all the relevant stakeholders from the outset.
• All appropriate approvals (REC, Sponsor’s Regulatory Green Light and MHRA) must be in place before recruitment can begin.
• Good trial management requires cooperation and collaboration so it is vital to maintain good relationships with colleagues.
Original languageEnglish
JournalBritish Medical Journal (BMJ)
Publication statusPublished - 26 Mar 2020


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